The Real World and Health Ascend: 1st Thoughts on NCCAM's Draft Strategic Plan 2011-2015
Written by John Weeks
Thursday, 02 September 2010
The Real World and Health Ascend: 1st Thoughts on NCCAM's Draft Strategic Plan 2011-2015
Summary: The comment period for the draft 2011-2015 Strategic Plan for the NIH National Center for Complementary and Alternative Medicineis open until September 30, 2010. The draft was posted August 30. This article provides an outline of key points in the 34-page NCCAM document including, as the plan's authors organize them: 4 conclusions from the team's landscape assessment; 3 overarching goals; 5 guideposts for keeping on track; 4 frames for priority-setting; and 5 strategic objectives. This, the 3rd NCCAM strategic plan, is the first from the Josephine Briggs, MD era as director. There is fine stuff here to celebrate relative to how research challenges are described, real-world research advocated, and an intriguing new focus advocated for examining the potential of complementary therapies and integrative practices in health-focused care and health promotion. I conclude with 5 reasons for excitement and 3 areas of concern. Kudos to Briggs and her team.
Following her appointment, Briggs began a long, thorough journey of listening and learning. She entered into dozens of forums and conferences and listened to hundreds of perspectives. Perhaps, one guesses, she allowed herself an experience or two of various modalities her office is charged with examining. Her schooling in these communities and the strength of her team are reflected in the draft produced. There is much to celebrate here. I first offer a Cliff's Notes version of the key elements to the 34-pages of the plan's structure and then some commentary.
Note: The bold subheadings below are from the plan itself.
4 conclusions from the landscape assessment
Briggs: The product of her period of listening
First, there is a compelling need for greater focus in setting research priorities.
Second, one of those areas of promise and need is in treating chronic pain.
Third, it has become clear that CAM modalities—whether pharmacological or mind/body and manual/manipulative—can and must be studied across the continuum of basic, translational, efficacy, and effectiveness research.
Finally, the strategic planning process forged a realization that although half of CAM use by Americans is aimed at improving general health, most CAM research to date has focused on the application of CAM practices to the treatment of various diseases and conditions.
3 over-arching goals
GOAL 1: Advance the science and practice of symptom management.
GOAL 2: Develop effective, practical, personalized strategies for promoting health and well being.
GOAL 3: Enable better evidence-based decision-making regarding CAM use and its integration into health care and health promotion.
5 guideposts for keeping progress on track:
First, targeted research and development efforts are required in selected instances to ensure progress.
Second, basic research to increase mechanistic understanding of CAM modalities remains essential.
Third, large clinical trials or effectiveness studies require a solid translational research foundation.
Fourth, research on the application of CAM modalities to health care and health promotion requires use of effectiveness and other “real-world” research methodologies.
Fifth, while a vast amount of information about CAM is available to the public, much of it is incomplete, misleading, inaccurate, or based on scientifically unproven claims.
4 (aspects of the) framework for priority setting
Scientific Promise
Amenability to Rigorous Scientific Inquiry
Potential To Change Health Practices
Extent and Nature of Practice and Use
5 Strategic Objectives
Advance research on CAM pharmacological interventions.
Advance research on mind/body and manipulative/manual CAM interventions and practices.
Increase understanding of “real-world” patterns and outcomes of CAM use and its integration into health care and health promotion.
Improve the capacity of the field to carry out rigorous research.
Develop and disseminate objective, evidence-based information on CAM interventions.
Analysis and Commentary: The day after the plan was released I had the opportunity to discuss it with a half-dozen researchers from the licensed complementary and alternative healthcare disciplines. Most of us electronically opened the package for the first time while on the call. While we skimmed, one or another would announce interesting pearls. Then someone would propose a change or two that might strengthen the direction. The general view that emerged was that there was plenty to work with and some fine signs of turns toward better reflecting the fields and how to examine its potential values.
As close observers of NCCAM's past plans will know, the proof of the pudding will be in how, exactly, the plan is carried out. Like a good poem, or an Obama campaign speech, the strategic plan can be vested with varying aspirations for the agency's future. Only time, and perhaps energy spent in influencing the agency, will tell whether the meaning one found in the words will be found in upcoming NCCAM programs. For the moment, I am mostly happily projecting great potential into this plan.
Top 5 Reasons for Excitement with NCCAM's Draft Strategic Plan
Emergence of health and health promotion One repeatedly encounters a focus on not merely disease/symptoms but also on "health care and health promotion." Many integrative practitioners have claimed that the endpoints on a good deal of historic NCCAM research have not begun to capture the health-creating value of their whole-person approaches. The plan notes the potential:
"A noteworthy degree of success in motivating and sustaining healthy behaviors change is often claimed by CAM and integrative medicine practitioners (page 25)."
The authors point to findings on consumer use that align with this health-focus. Roughly half of consumers use of CAM is for purposes of health betterment. The 4th "conclusion," GOAL 3, the 5th "guidepost," the 3rd priority-setting bullet and 3rd Strategic Objective all reference this direction. Back in the day, this was called the "paradigm shift" that "alternative medicine" represented. Nice to see NCCAM catching up to its primary practitioner audience and the "prevention systems" (to use Congressional mandate language term) that they represent.
"Real world research" For months, Briggs has been talking about real world research, linked in the plan, as in many integrative practices, to the focus on health creation. The real world is directly referenced in the 3rd Strategic Objective. The "types of outcomes of particular interest," the authors note on page 25, "include well-being, functional status, quality of life, patient satisfaction, and costs, in addition to measures of morbidity and changes in disease status." See recent Integrator article on the outcomes of the Seely-Herman/Canada Post controlled trial as an example. The value to stakeholders in the mainstream delivery system of such research outcome can be quiet broad, as evidenced in this discussion of the Seely-Herman outcomes. The plan authors note that real world outcomes include capturing "health-promoting behaviors and practices" (page 24).
Focus on pain This focus is just plain smart, as in low-hanging fruit, and plenty of it. A significant portion of CAM use is for pain conditions. In addition, this moment in time is one in which pain is gaining a bump in focus, as we deal with unintended consequences of the JCAHO pain standard issued nearly a decade ago. The Institute of Medicine is currently empaneling a team for a pain-related study and I have heard that more than one national pain-related initiatives are underway, including one led through the Center for Practical Bioethics to create a national strategy on pain care.
Understanding of the field(s) The fabric of the strategic plan is knit together via analysis of aspects of the field that show the learning of both NCCAM's past decade and Briggs' own listening period. The list of challenges in research on natural pharmacy, including dose, product-choice, administration, and outcomes selected are an example (page 11). Appreciation for the health-orientation of both consumer use and practitioner approaches, noted above, is another area. Similarly, the "common challenges" in researching many CAM practitioner approaches (shams, masking, non-specific effects, etc.) are clearly and succinctly described (page 17). Clearly announcing these challenges, and the implication that these approaches may need specialized research modeling, is a sign of strength.
Abandonment of "biologically-based" as a descriptive CAM category A footnote on page 11 notes that the authors will interchangeably use "CAM pharmacological" and "CAM natural product (NP)," adding: "The term 'biologically-based' has been abandoned because other CAM modalities have and/or exert biologically-based effects." Good.
Top 3 Concerns with the Plan
Harkin: The real world was the priority in his plan
Priorities don't yet match the outcomes focus of the Congressional/Harkin mandate The 1998 enabling act from Congress that established NCCAM offers a kindergartner's guide to Congressional priorities. The priorities are marked in a 1-5 order, plus an "other" category, in Section F. The plan's elevation of the NIH's comfort zone of pharma research to Strategic Objective #1 is not aligned with this Congressional intent. Natural products were not mentioned, as such, in the mandate. For Congress, "outcomes" (#1) and "health services" (#3) both rank higher than "basic research" (#4) and clinical trials (#5). Strategic Objective #3, real world research and health outcomes, should be in the first position, announced clearly as the top strategic objective. What might we learn in 5-10 years if the message of this plan to the research community, via such a top objective, was: If you want to be funded, hone your skills in connecting to the real world. That's where we're driving this agency. To realize its great potential for the public health, Strategic Objective #3 requires promoting a sea-change in approach and training of integrative researchers so they can be masters of new models and methods. I hear voices of colleagues in my ear saying: Hey, appreciate what is here. They can only stray so far from the dominant NIH culture. Well, maybe. How about at least a 3rd of the NCCAM budget - $45-million a year -- focusing on this strategic objective?
Little focus on examining "whole practices" or "disciplines" This is a similar issue. If we wish to help stakeholders in the payment and delivery system (see Section C of the mandate) decide whether or not to included new disciplines (chiropractic doctors or naturopathic physicians, massage practitioners, yoga therapists, licensed acupuncturists, holistic nurses or even integrative medical doctors) into their programs and facilities, we need to be directly examining what happens when one does so. The discussion around the 4th "mapping" bullet (page 10) is smart to reference learning from methods from research fields that are familiar with "multi-component interventions." Yet the document doesn't lead with appreciation that these multi-component approaches are the rule, not the exception. All integrative practice groups urged what would seem a higher elevation of this direction in their recommendations on the plan last fall. The document as it sits is a gradualist entry into examining what actually happens in integrative practice. Better than in the past, but not yet enough.
No focus on capacity building in CAM institutions The plan shows sensitivity to the importance of educating CAM practitioners for "rigorous collaborative research." But the Strategic Objective #4 on capacity building does not yet recognize the potency of directly investing in building energy and competence in CAM academic centers. Instead, we have what leaders from licensed CAM fields speak of as a "brain drain" from their institutions. Career paths for most of their best clinician researchers typically require that they get jobs in conventional academic health centers. While such a choice has obvious benefits (accessing more resources, expertise, infrastructure, etc.) there are significant losses when these researchers create their future by modeling their questions and proposals on what fits in a conventional research center. Building the culture of research in the CAM schools and shaping distinctly CAM environments where internal teams can gestate the questions and processes of most interest to them, ith collaborative support from conventional centers, could have remarkable value. Robust research communities will not form on CAM school campuses unless resources are directed toward these institutions. The present plan appears to foster the brain drain. Hopefully this can be amended.
My last concern on reading this plan is actually more of a wish and a what-if. And that is: What if NCCAM was able to say that doing natural product research is not our job. The high use of such products by the public suggests that someone should be doing it. Yet the presence of this comfortable, reductive (even with its challenges), pharma-focus in NCCAM's house is a distraction. CAM pharmacologicals represent a residual ideology. Given the challenges of real world models, one can imagine how the home-and-known of a good old-fashioned single agent RCT might beckon like a pacifier.
Such natural product work pulls the agency away from its best destiny: to impact both science and the health care of individuals by clarifying how to best measure and examine the outcomes of multi-agent, multi-modal, whole person, health-oriented, holistic, natural health and integrative practices. NCCAM's power resides here. The models to do this work are and will be challenging, as is noted repeatedly in this plan. The best may be yet to be invented. That sounds interesting. Take it on with a vengeance!
This draft strategic plan announces NCCAM's intention to embrace this health-focused, complex destiny, even if yet as a secondary element. Briggs and her author team should be commended. Now to make a few adjustments and engage these emerging themes, in all of their dimensions.
